- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311096
Interscalene Block Versus Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery
December 16, 2025 updated by: Omer Doymus, Erzurum Regional Training & Research Hospital
Comparison of the Effectiveness of Interscalene Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Patients Undergoing Arthroscopic Shoulder Surgery
This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and serratus posterior superior intercostal plane block (SPSIP) for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery.
The primary outcome is total 24-hour opioid consumption.
Secondary outcomes include pain scores, hemidiaphragmatic paresis incidence and severity, duration of analgesia, and changes in lung function.
Participants are randomized into ISB or SPSIP groups; blocks are performed under ultrasound guidance.
Postoperative pain is managed with patient controlled analgesia(PCA).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yakutiye
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Erzurum, Yakutiye, Turkey (Türkiye), 25100
- Erzurum Regional Training Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Agreeing to participate in the study
- The American Society of Anesthesiologists I-III
- Scheduled for elective unilateral arthroscopic shoulder surgery
Exclusion Criteria:
- Refusal to participate in the study
- Allergy to the medications to be used
- History of serious heart, kidney or liver disease
- Neurological deficits or neuropathy
- History of anticoagulant use
- Pre-existing operative respiratory dysfunction
- Having chronic shoulder pain
- Being about to undergo open surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interscalene Brachial Plexus Block (ISB)
Patients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine.
|
Patients receive ultrasound-guided ISB before arthroscopic shoulder surgery.
15 ml of 0.25% bupivacaine is injected using a 22 Gauge 50 mm needle with posterior in-plane approach, targeting C5-C6 roots.
|
|
Experimental: Serratus Posterior Superior Intercostal Plane Block
Patients will receive SPSIP block under ultrasound guidance using 30 ml 0.25% bupivacaine
|
Patients receive ultrasound-guided SPSIP interfascial block in sitting position before surgery.
Using a 22 Gauge 10 mm needle, 30 ml of 0.25% bupivacaine is injected between serratus posterior muscle and second rib.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total 24-Hour Postoperative Opioid Consumption
Time Frame: 0-24 hours postoperatively
|
Total intravenous opioid consumption recorded for each patient during the first 24 hours after arthroscopic shoulder surgery, including any rescue analgesia administered.
|
0-24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and Severity of Hemidiaphragmatic Paresis
Time Frame: Pre-block and 30 minutes post-block
|
Ipsilateral hemidiaphragmatic function evaluated by M-mode ultrasonography before block and 30 minutes after block completion.
Paresis classified as none (<25% reduction), partial (25-75% reduction), or complete (>75% reduction or paradoxical movement).
|
Pre-block and 30 minutes post-block
|
|
Pulmonary Function Changes (FEV1)
Time Frame: Pre-block and 30 minutes post-block
|
Pulmonary function measured with bedside spirometry pre-block and 30 minutes post-block.
Forced expiratory volume in 1 second (FEV1) recorded; each measurement performed three times and mean value used.
|
Pre-block and 30 minutes post-block
|
|
Pulmonary Function Changes (FVC)
Time Frame: Pre-block and 30 minutes post-block
|
Pulmonary function measured with bedside spirometry pre-block and 30 minutes post-block.
Forced vital capacity (FVC) recorded; each measurement performed three times and mean value used.
|
Pre-block and 30 minutes post-block
|
|
Duration of Analgesia
Time Frame: Time interval from block completion to initiation of IV PCA fentanyl in each patient
|
0-24 hours post-block
|
Time interval from block completion to initiation of IV PCA fentanyl in each patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ömer Doymus, MD, Erzurum Regional Training & Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kumari P, Kumar A, Aliyar R, Sinha L. Continuous serratus posterior superior intercostal plane block for postoperative analgesia in thoracotomy. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101570. doi: 10.1016/j.accpm.2025.101570. Epub 2025 Jun 14. No abstract available.
- Dogan G, Kucuk O, Kayir S, Dal GC, Ciftci B, Zengin M, Alagoz A. Serratus posterior superior intercostal plane block versus thoracic paravertebral block for pain management after video-assisted thoracoscopic surgery: a randomized prospective study. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844647. doi: 10.1016/j.bjane.2025.844647. Epub 2025 Jun 3.
- Ozen V, Turan EI, Alver S, Ciftci B, Cakir I, Sahin AS. Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in a Pediatric Patient Undergoing Lobectomy: A Case Report. A A Pract. 2025 May 27;19(5):e01988. doi: 10.1213/XAA.0000000000001988. eCollection 2025 May 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
December 15, 2025
Study Registration Dates
First Submitted
December 16, 2025
First Submitted That Met QC Criteria
December 16, 2025
First Posted (Actual)
December 30, 2025
Study Record Updates
Last Update Posted (Actual)
December 30, 2025
Last Update Submitted That Met QC Criteria
December 16, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Joint Diseases
- Neurobehavioral Manifestations
- Arthralgia
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Shoulder Pain
- Agnosia
Other Study ID Numbers
- SBUERZURUMSHOULDER
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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